Find & Apply For Quality Control Systems Manager Jobs in Holliston, Massachusetts

Browse jobs from a variety of sources below, sorted with the most recently published, nearest to the top. Click the title to view more information and apply online.

Skip to job details

Now viewing: RA/QA Director

Apply for this opportunity

To apply for this job, you'll continue to an external website or email application.

Apply Offsite

NeuroSync Inc.

RA/QA Director

Pay: $160,000–$180,000/yr

Posted: 3 weeks ago

Location: Holliston, MA (Onsite)

Last Updated: 3 weeks ago

Hours: Full-Time

Expires: 9/22/2026

Job Description

Who we are: NeuroSync is a pioneering neurotechnology company that delivers a cutting-edge digital health platform for objective brain health assessments and performance optimization. Trusted by leading medical centers, military, and sports organizations, our mission is to revolutionize brain health care.

Key Responsibilities:

Lead Quality and Regulatory areas as part of the leadership team. Oversee quality and regulatory activities for Class II devices/

SaMD:

registration/listing, UDI/GUDID, and change control. Serve as primary liaison for FDA submissions and interactions. Maintain QMS compliance (ISO 13485, QMSR) and ensure audit/inspection readiness. Partner with Engineering and Clinical departments on product development - risk management, usability, SaMD lifecycle, cybersecurity, and technical files.

Oversee post-market surveillance:

complaints, performance monitoring, and continuous improvement.

Ensure manufacturing and release quality:

inspections, DHRs, equipment, and validation support. Lead audits and inspections, compliance metrics and Management Review inputs, while guiding cross-functional teams.

Skills & Qualifications:

5+ years minimum in medical device Regulatory Affairs and Quality with health tech experience in the U.S. Class II or III experience. Proven work on 510(k) submissions, maintenance/changes (letters-to-file), registration/listing, UDI/GUDID, and running CAPA and post market complaints Working knowledge of

ISO 13485, ISO 14971, IEC

62304 and

IEC 62366

Excellent technical writing, organization, and cross-functional communication; able to operate as the day-to-day RA/QA lead. Experience with software/hardware (SaMD) combinations is beneficial. Bachelor's degree, ideally in engineering, life sciences, or related field, required. Master's degree preferred.

Compensation:

$160,000-$180,000 including bonus plus equity

Pay:

$160,000.00 - $180,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person